CALCIUM CHLORIDE- calcium chloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

International Medication Systems, Limited

INN (International Name):

Calcium Chloride

Composition:

Calcium Chloride 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity.    Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation. None known.

Product summary:

10% Calcium Chloride Injection, USP is supplied in single-dose containers as follows: One shrink wrapped package containing 10 unit cartons, each containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.] Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM CHLORIDE - CALCIUM CHLORIDE INJECTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
----------
10% CALCIUM CHLORIDE
INJECTION, USP
RX ONLY
1 G/10 ML (100 MG/ML)
Represents 27 mg (1.4 mEq) Ca++/mL
A HYPERTONIC SOLUTION IN A 10 ML SINGLE-DOSE SYRINGE FOR PROMPT
INTRAVENOUS INJECTION.
CAUTION: THIS SOLUTION MUST NOT BE INJECTED INTRAMUSCULARLY OR
SUBCUTANEOUSLY. ADMINISTER ONLY BY SLOW INJECTION (NOT TO EXCEED 1
ML/MINUTE)
DESCRIPTION
10% Calcium Chloride Injection, USP is a sterile, nonpyrogenic,
hypertonic solution. Each
mL contains 100 mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4
mEq each of Ca
and Cl ) in water for injection. It is provided in a 10 mL Single-Dose
Syringe to facilitate
prompt intravenous injection. The solution contains no bacteriostat,
antimicrobial agent
or added buffer and is intended for use only as a single-dose
injection. The pH of 10%
Calcium Chloride Injection, USP is 5.5 to 7.5 when diluted with water
for injection to make
a 5% solution. May contain hydrochloric acid and/or sodium hydroxide
for pH
adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10%
Calcium
Chloride Injection, USP is oxygen sensitive.
Calcium Chloride, USP dihydrate is chemically designated CaCl
• 2H O (dihydrate) and
is described as white, odorless fragments or granules freely soluble
in water.
CLINICAL PHARMACOLOGY
Calcium chloride in water dissociates to provide calcium (Ca
) and chloride (Cl ) ions.
They are normal constituents of the body fluids and are dependent on
various
physiological mechanisms for maintenance of balance between intake and
output.
Approximately 80% of body calcium is excreted in the feces as
insoluble salts; urinary
excretion accounts for the remaining 20%.
INDICATIONS AND USAGE
10% Calcium Chloride Injection, USP is indicated for the treatment of
hypocalcemia in
those conditions requiring a prompt increase in plasma calcium levels.
CONTRAINDICATIONS
Calcium chloride is contraindicated for cardiac resuscitation in the
presence of
ventricular fibrillation or in patien